세계의 PD-1 및 PD-L1 억제제 시장 - 인사이트, 역학, 시장 예측(2034년)
PD-(L)1 Inhibitors - Market Insight, Epidemiology, and Market Forecast - 2034
상품코드 : 1553389
리서치사 : DelveInsight
발행일 : 2024년 08월
페이지 정보 : 영문 298 Pages
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한글목차

주요 하이라이트

PD-L1 억제제 시장 전망

PD-1 억제제는 향후 판매 측면에서 주요 약물 등급이 될 것으로 예측됩니다. 면역종양제, 특히 PD-L1 클래스는 전이성부터 조기 단계까지 다양한 종양 유형과 병기에 걸친 암 치료를 일변시켰습니다. PD-L1 요법의 채용은 증명된 다양성에 의해 추진되어 왔습니다. PD-L1 요법은 단일 요법으로도 티로신 키나아제 억제제, 화학 요법 및 기타 면역 요법 제와 같은 분자 표적 약물과 함께 사용할 수 있습니다. 이 범용성은 허용 가능한 독성 프로파일을 유지하면서 지속적인 종양 반응과 생존율을 향상시킵니다. PD-L1 요법은 화학요법에 비해 안전성 프로파일이 개선되었으므로 광범위한 병용 요법에서 백본 요법으로 사용할 수 있습니다.

면역체크포인트 억제제, 특히 PD-L1 억제제는 암 치료의 획기적인 진보입니다. 그러나 PD-L1 이외의 새로운 표적의 개발은 문제에 직면하고 있습니다. TIGIT와 TIM-3은 한때 유망한 새로운 표적이었지만, 큰 실패를 경험한 후 진행은 제한적입니다. 그럼에도 불구하고 TIM-3과 TIGIT 제품은 현재 개발 중입니다. LAG-3도 잠재적인 표적입니다. 이와는 별도로, MHC 클래스 II 작용제로서의 Efti의 독특한 차별화된 접근법은 병용 요법의 매력적인 표적이 됩니다.

혼잡한 PD-L1 영역에서는 차별화가 성공의 핵심입니다. 기업은 혁신적이기 위해 노력하고 현재의 치료법이 최적이 아닌 영역을 다루어야 합니다. 새로운 적응증으로 동급 최고가 되거나 화이트 스페이스에 임하는 것도 이 경쟁 환경에서 기업이 두드러지게 됩니다. 새로운 PD-L1 억제제로는 스파르타리주맙(Novartis), 사산리맙(Pfizer), 짐베렐리맙(Arcus Biosciences), 수게마리맙(EQRx/Stone Pharmaceuticals), HLX10(Shanghai Henlius Biotech), 발스티리맙(Agenus) 등이 있습니다.

본 보고서에서는 PD-L1 억제제의 주요 7개 시장(미국, 독일, 스페인, 이탈리아, 프랑스, 영국, 일본)에 대한 조사 분석을 실시하고, 각 지역 시장 규모, 현재의 치료법, 암메트니즈, 신약 등 정보를 제공합니다.

목차

제1장 중요 인사이트

제2장 보고서 소개

제3장 PD-L1 억제제의 주요 요약

제4장 주요 사건

제5장 역학과 시장 예측 조사 방법

제6장 주요 7개 시장의 PD-L1 억제제 시장 개요

제7장 PD-L1 억제제의 배경과 개요

제8장 역학과 환자 인구

제9장 출시 끝난 약품

제10장 신약

제11장 PD-1 및 PD-L1 억제제: 주요 7개 시장 분석

제12장 미충족 요구

제13장 SWOT 분석

제14장 KOL의 견해

제15장 시장 진입과 상환

제16장 부록

17장 DelveInsight 기능

제18장 면책사항

제19장 DelveInsight 정보

JHS
영문 목차

영문목차

Key Highlights:

DelveInsight's "PD-(L)1 Inhibitors - Market Insight, Epidemiology and Market Forecast - 2034" report delivers an in-depth analysis of PD-(L)1 inhibitors epidemiology, market, and clinical development understanding of PD-(L)1 inhibitors. In addition, this report provides historical and forecasted epidemiology and market data as well as a detailed analysis of the PD-(L)1 inhibitors market trends in the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan.

PD-(L)1 inhibitors market report provides real-world prescription pattern analysis, emerging drugs assessment, market share, and uptake/adoption pattern of individual therapies, as well as historical and forecasted PD-(L)1 inhibitors market size from 2020 to 2034 in the 7MM. The report also covers current PD-(L)1 inhibitors treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's underlying potential.

Geography Covered:

PD-(L)1 Inhibitors Understanding and Treatment Algorithm

PD-(L)1 Inhibitors Overview

Over the last decade, immune checkpoint inhibitors have revolutionized cancer care, offering patients an alternative to chemotherapy or targeted therapies and a chance at long-term remission across many tumor types. The first two immune checkpoint receptors for which clinically efficient inhibitors were successfully developed were the cytotoxic lymphocyte antigen-4 (CTLA-4) and the PD-1 receptor. Most solid tumors and a subset of hematologic malignancies benefit from using one or both drug classes. While immune checkpoint inhibitors were initially evaluated and approved for the treatment of metastatic cancers, their use has now expanded to include early-stage cancer in certain tumor types, such as triple-negative breast cancer or non-small-cell lung cancer. PD-1 is a checkpoint protein in T cells that acts as a type of "off switch" that helps keep the T cells from attacking other cells in the body, especially when it attaches to PD-(L)1 - a protein on some normal (and cancer) cells. Some cancer cells have large amounts of PD-(L)1, which helps them hide from an immune attack. Monoclonal antibodies that target either PD-1 or PD-(L)1 can block this binding and boost the immune response against cancer cells. Examples of drugs that target PD-1 include KEYTRUDA, OPDIVO, and LIBTAYO. Examples of drugs that target PD-(L)1 include TECENTRIQ, BAVENCIO, and IMFINZI. Both PD-1 and PD-(L)1 inhibitors help treat different types of cancer.

There are many emerging PD-(L)1 inhibitors entering clinical trials. The developing pipeline of immune checkpoint inhibitors may lead to improvements in efficacy and tolerability rates for PD-1 inhibition. Spartalizumab, sugemalimab, HLX10, INCB99280, balstilimab, envafolimab, and others are currently being investigated for various cancers, including advanced hepatocellular carcinoma, melanoma, urothelial carcinoma bladder, metastatic esophageal cancer, metastatic gastric cancer, NSCLC, and others.

PD-(L)1 Inhibitors Epidemiology

PD-(L)1 Inhibitors Drug Chapters

The drug chapter segment of the PD-(L)1 inhibitors report encloses a detailed analysis of PD-(L)1 inhibitors marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also deep dives into the PD-(L)1 inhibitors pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations.

Marketed Drugs

KEYTRUDA (pembrolizumab): Merck

KEYTRUDA is a PD-1-blocking antibody. It is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-(L)1 and PD-(L)2, thereby activating T lymphocytes, which may affect both tumor cells and healthy cells. In some cancers, it is only given to patients whose tumors produce high protein levels known as PD-(L)1. It is approved for multiple types of cancer. It was first approved by the FDA in September 2014 for advanced melanoma. Since then, it has received multiple approvals, and the latest FDA approval was in January 2024 as a treatment for patients with FIGO 2014 Stage III-IVA cervical cancer. In February 2024, Merck announced that the US FDA has accepted for priority review a new sBLA seeking approval for KEYTRUDA in combination with standard-of-care chemotherapy (carboplatin and paclitaxel), followed by KEYTRUDA as a single agent for the treatment of patients with primary advanced or recurrent endometrial carcinoma. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of June 21, 2024.

IMFINZI (durvalumab): AstraZeneca

IMFINZI is a human monoclonal antibody that binds to PD-(L)1 and blocks the interaction of PD-L1 with PD 1 and CD80, countering the tumor's immune-evading tactics and releasing the inhibition of immune responses. It is approved in four indications, NSCLC, ES-SCLC, BTC, and HCC. The first FDA approval of IMFINZI was in February 2018 for patients with Stage III NSCLC. The company is expecting an FDA decision for IMFINZI as neoadjuvant therapy in the AEGEAN trial in the first half of 2024 for small-cell lung cancer, and the company is anticipating Phase III data readout of the NILE trial in first-line bladder cancer in the second half of 2024.

Emerging Drugs

Sugemalimab (CS1001): EQRx/CStone Pharmaceuticals

Sugemalimab (CS1001) is an investigational anti-PD-L1 monoclonal antibody discovered by CStone. Authorized by the US-based Ligand Corporation, sugemalimab is developed by the OmniRat transgenic animal platform, which can generate fully human antibodies in one stop. As a fully human, full-length anti-PD-L1 monoclonal antibody, sugemalimab mirrors the natural G-type immunoglobulin 4 (IgG4) human antibody, which can reduce the risk of immunogenicity and potential toxicities in patients, a unique advantage over similar drugs. The drug is currently in Phase III clinical trial for the treatment of patients with metastatic NSCLC, and extranodal NK/T-cell lymphoma. The company is anticipating an opinion from the CHMP to the MAA for the first-line treatment of Stage IV NSCLC in the EU in the first half of 2024, MAA approval in the second half of 2024, and the MAA approval for the first-line treatment of Stage IV NSCLC in the UK in the second half of 2024. In December 2023, CStone and the US FDA reached an agreement in a Type B consultation regarding the registration pathway for R/R ENKTL indication. The company will also discuss with the US FDA regarding registration pathways for gastric/gastroesophageal junction adenocarcinoma and ESCC indications in the future.

Sasanlimab: Pfizer

Sasanlimab is a humanized immunoglobulin G4 monoclonal antibody that binds to the programmed cell death (PD-1) receptor and blocks its interaction with PD-1 ligands. Sasanlimab blocks the interaction between PD-1 and PD-L1/-L2, thus releasing the PD-1 pathway-mediated inhibition of the immune response and leading to an antitumor immune response. Sasanlimab has been shown to induce T-cell proliferation and secretion of interferon-? and other pro-inflammatory cytokines in human-activated CD8+ T cells. Currently, the company is conducting a pivotal Phase III CREST study of sasanlimab in people with non-muscle invasive bladder cancer. The company anticipates data readout from the Phase III trial of sasanlimab for BCG-naive, high-risk non-muscle invasive bladder cancer by the first half of 2025.

Drug Class Insights

Checkpoint inhibitors targeting PD-(L)1 have emerged as dominant forces in the immunotherapy landscape for cancer treatment, with ten PD-(L)1 inhibitors approved, comprising seven PD-1 and three PD-L1 inhibitors in the United States. Their efficacy has been notable across various solid tumors, with KEYTRUDA being a standout among these agents, approved for a remarkable twenty indications and holding a significant market presence for several years. However, recent concerns over adverse events have prompted a shift towards combination approaches aimed at enhancing both efficacy and safety. This strategy involves combining PD-(L)1 inhibitors with other checkpoint inhibitors such as CTLA-4, TIGIT, and LAG-3, as well as exploring novel targets like TROP-2. Despite their potential, immune checkpoint inhibitors face challenges including immune-related side effects and high costs, highlighting the critical need for reliable biomarkers to identify patients who would benefit most from these treatments.

PD-(L)1 Inhibitors Market Outlook

PD-1 inhibitors are expected to be the leading drug class in terms of sales in the future. Immuno-oncology agents, especially the PD-(L)1 class, have transformed cancer treatment across various tumor types and stages, from metastatic to early stage. The adoption of PD-(L)1 therapies has been driven by their proven versatility. They can be used as monotherapy or in combination with targeted agents like tyrosine kinase inhibitors, chemotherapy, or other immunotherapy agents. This versatility has led to durable tumor responses and improved survival benefits, all while maintaining acceptable toxicity profiles. The improved safety profile of PD-(L)1 therapies compared to chemotherapy allows them to be used as a backbone therapy in a wide range of combination regimens.

Immune checkpoint inhibitors, particularly PD-(L)1 inhibitors, have been a breakthrough in cancer treatment. However, the development of new targets beyond PD-(L)1 has faced challenges. TIGIT and TIM-3 were once promising new targets but have seen limited progress after experiencing high-profile failures. Despite this, both TIM-3 and TIGIT products are still in development. LAG-3 is another potential target. Apart from this Efti's unique and differentiated approach as an MHC Class II agonist makes it an attractive target for combination therapies.

In the crowded PD-(L)1 landscape, differentiation is key to success. Companies must strive to be innovative and address areas where current therapies are sub-optimal. Being the first-in-class in new indications or addressing white space can also help companies stand out in this competitive environment. The emerging PD-(L)1 inhibitors include, spartalizumab (Novartis), sasanlimab (Pfizer), zimberelimab (Arcus Biosciences), sugemalimab (EQRx/CStone Pharmaceuticals), HLX10 (Shanghai Henlius Biotech), balstilimab (Agenus), and others.

PD-(L)1 Inhibitors Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020-2034, which depends on the competitive landscape, safety, efficacy data along with order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.

Further detailed analysis of emerging therapies drug uptake in the report...

PD-(L)1 Inhibitors Activities

The report provides insights into different therapeutic candidates in Phase III and Phase II stages. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for PD-(L)1 Inhibitors emerging therapies.

KOL Views

To keep up with the real-world scenario in current and emerging market trends, we take opinions from Key Industry leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient's therapy switching acceptability, and drug uptake along with challenges related to accessibility, including Medical/scientific writers, Medical Oncologists, Pulmonologists and Professors, Chief of Thoracic Service at the Memorial Sloan Kettering Cancer Center, Dermatologists at the Johns Hopkins Hospital, and Others.

Delveinsight's analysts connected with 40+ KOLs to gather insights; however, interviews were conducted with 18+ KOLs in the 7MM. Centers such as MD Anderson Cancer Center, Texas, UT Southwestern Medical Center in Dallas, Cancer Research UK Barts Centre in London, LUNGevity Foundation, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or PD-L(1) inhibitors market trends.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and analyst views. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Market Access and Reimbursement

In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs, including Medicare, Medicaid, the Children's Health Insurance Program (CHIP), and the state and federal health insurance marketplaces, are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs) and third-party organizations that provide services and educational programs to aid patients are also present. The Inflation Reduction Act (IRA) authorizes the Secretary of the Department of Health and Human Services (HHS) to negotiate prices directly with participating manufacturers for certain high expenditures, qualifying single-source Medicare drugs without generic or biosimilar competition. Negotiations with participating manufacturers for the first group of 10 drugs selected for the first cycle of Medicare drug price negotiations began in 2023, with any negotiated maximum fair prices going into effect in 2026. In 2026-2028, it is estimated that Medicare will negotiate prices for 38 Medicare Part D drugs and 2 Part B drugs. KEYTRUDA and OPDIVO come under Part B drugs.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report:

PD-(L)1 Inhibitors Report Insights

PD-(L)1 Inhibitors Report Key Strengths

PD-(L)1 Inhibitors Report Assessment

FAQs:

Reasons to buy:

Table of Contents

1. KEY INSIGHTS

2. REPORT INTRODUCTION

3. EXECUTIVE SUMMARY OF PD-(L)1 INHIBITORS

4. KEY EVENTS

5. EPIDEMIOLOGY AND MARKET FORECAST METHODOLOGY

6. PD-(L)1 INHIBITORS MARKET OVERVIEW AT A GLANCE IN THE 7MM

7. PD-(L)1 INHIBITORS BACKGROUND AND OVERVIEW

8. EPIDEMIOLOGY AND PATIENT POPULATION

9. MARKETED DRUGS

10. EMERGING DRUGS

11. PD-(L)1 INHIBITORS: THE 7MM ANALYSIS

12. UNMET NEEDS

13. SWOT ANALYSIS

14. KOL VIEWS

15. MARKET ACCESS AND REIMBURSEMENT

16. APPENDIX

17. DELVEINSIGHT CAPABILITIES

18. DISCLAIMER

19. ABOUT DELVEINSIGHT

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